DABIPRAX 110 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dabiprax 110 mg Hard Capsules EFG

dabigatran etexilate

Readtheentirepackageleafletcarefullybeforeyoustarttakingthismedicinebecauseitcontainsimportantinformationforyou.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contentsofthepackageleaflet

1. What is Dabiprax and what is it used for
2. What you need to know before you take Dabiprax
3. How to take Dabiprax
4. Possible side effects
5. Storage of Dabiprax
6. Package contents and further information

1. What is Dabiprax and what is it used for

Dabiprax contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in the formation of blood clots.

Dabiprax is used in adults to:

• prevent the formation of blood clots in the veins after knee or hip replacement surgery.

• prevent the formation of blood clots in the brain (stroke) and in other blood vessels of the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and have at least one additional risk factor.

• treat blood clots in the veins of your legs and lungs and to prevent them from happening again in the veins of your legs and lungs.

Dabiprax is used in children to:

• treat blood clots and prevent them from happening again.

2. What you need to know before you take Dabiprax

Do not take Dabiprax

• if you are allergic to dabigatran etexilate or any of the other ingredients of this medicine (listed in section 6).
• if your kidney function is severely reduced.
• if you are currently bleeding.
• if you have a disease in an organ of the body that increases the risk of severe bleeding (e.g. stomach ulcer, bleeding or injury to the brain, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be inherited, of unknown cause, or caused by other medicines.
• if you are taking medicines to prevent blood clotting (e.g. warfarin, rivaroxaban, apixaban, or heparin), except when switching from one anticoagulant treatment to another, while having a venous or arterial catheter and being administered heparin through this catheter to keep it open, or while your normal heartbeat is being restored through a procedure called catheter ablation for atrial fibrillation.
• if your liver function is severely reduced or you have a life-threatening liver disease.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral ciclosporin, a medicine used to prevent organ rejection after a transplant.
• if you are taking dronedarone, a medicine used to treat irregular heartbeat.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires permanent anticoagulant treatment.

Warnings and precautions

Talk to your doctor before starting to take Dabiprax. During treatment with this medicine, you may also need to talk to your doctor if you experience any symptoms or if you need to have surgery.

Tell your doctorif you have or have had any disorder or disease, especially any of the following:

• If you have an increased risk of bleeding, for example:
• • if you have recently had bleeding.
  • if you have had a surgical tissue removal (biopsy) in the last month.
  • if you have had a severe injury (e.g. a bone fracture, a head injury, or any injury that required surgical treatment).
  • if you have inflammation of the esophagus or stomach.
  • if you have problems with stomach acid reflux into the esophagus.
  • if you are taking medicines that may increase the risk of bleeding. See "Other medicines and Dabiprax" below.
  • if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.
  • if you have a heart infection (bacterial endocarditis).
  • if you know you have reduced kidney function or if you are dehydrated (symptoms include feeling thirsty and passing small amounts of dark-colored urine).
  • if you are over 75 years old.
  • if you are an adult patient and weigh 50 kg or less.
  • only if used in children: if the child has a brain infection or around the brain.

• If you have had a heart attack or if you have been diagnosed with diseases that increase the risk of having a heart attack.

• If you have a liver disease associated with changes in blood tests. The use of this medicine is not recommended in this case.

Be careful with Dabiprax

• If you need to have surgery:

In this case, dabigatran should be temporarily stopped due to an increased risk of bleeding during and after surgery. It is very important that you take this medicine before and after surgery exactly at the times indicated by your doctor.

• If surgery requires the placement of a catheter or injection into the spinal column (e.g. for epidural or spinal anesthesia or for pain relief):
• • It is very important that you take Dabiprax before and after surgery exactly at the times indicated by your doctor.
  • Tell your doctor immediately if you experience numbness or weakness in your legs or bowel or bladder problems after the end of anesthesia, as this situation requires urgent attention.

• If you fall or injure yourself during treatment, especially if you hit your head. Seek urgent medical attention. You may need a doctor to examine you, as you may have a higher risk of bleeding.

• If you know you have a disease called antiphospholipid syndrome (a disorder of the immune system that increases the risk of blood clots), tell your doctor so that they can decide if it is necessary to modify the treatment.

Other medicines and Dabiprax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must tell your doctor before taking Dabigatran if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g. warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid)
• Medicines for the treatment of fungal infections (e.g. ketoconazole, itraconazole), except if only applied to the skin
• Medicines used in the treatment of irregular heartbeat (e.g. amiodarone, dronedarone, quinidine, verapamil)

If you are using medicines that contain amiodarone, quinidine, or verapamil, your doctor may instruct you to use a reduced dose of Dabiprax according to the disease for which it was prescribed. See section 3.

• Medicines for the prevention of organ rejection after a transplant (e.g. tacrolimus, ciclosporin)
• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C)
• Anti-inflammatory and pain-relieving medicines (e.g. acetylsalicylic acid, ibuprofen, diclofenac)
• St. John's Wort, a herbal medicine for depression
• Antidepressant medicines called selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors
• Rifampicin or clarithromycin (two antibiotics)
• Antiviral medicines for HIV (e.g. ritonavir)
• Certain medicines for the treatment of epilepsy (e.g. carbamazepine, phenytoin)

Pregnancy and breastfeeding

The effects of dabigatran on pregnancy and the fetus are unknown. You should not use this medicine if you are pregnant unless your doctor tells you it is safe to do so. If you are of childbearing age, you should avoid becoming pregnant during treatment with this medicine.

Breastfeeding is not recommended during treatment with Dabiprax.

Driving and using machines

Dabigatran has no known effects on the ability to drive and use machines.

Dabiprax contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which is essentially "sodium-free".

3. How to take Dabiprax

Dabiprax capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. There are other pharmaceutical forms suitable for the treatment of children under 8 years.

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor again.

Take Dabiprax as recommended for the following situations:

Prevention of blood clot formation after knee or hip replacement surgery

The recommended dose is 220 mg once a day(administered in the form of 2 capsules of 110 mg).

If your kidney function is reducedby more than half or if you are 75 years of age or older, the recommended dose is 150 mg once a day(administered in the form of 2 capsules of 75 mg).

If you are using medicines that contain amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once a day(administered in the form of 2 capsules of 75 mg).

If you are using medicines that contain verapamil and your kidney function is reducedby more than half, you should be indicated a reduced dose of dabigatran of 75 mgbecause your risk of bleeding may increase.

In both types of surgery, treatment should not be started if there is bleeding at the surgical site. If treatment cannot be started until the day after the operation, dosing should be started with 2 capsules once a day.

After knee replacement surgery

Treatment with dabigatran should be started 1-4 hours after surgery, taking a single capsule. After that, 2 capsules should be taken once a day for a total of 10 days.

After hip replacement surgery

Treatment with Dabigatran should be started 1-4 hours after surgery, taking a single capsule. After that, 2 capsules should be taken once a day for a total of 28-35 days.

Prevention of cerebral or systemic vascular obstruction by blood clot formation after irregular heartbeat and treatment of blood clots in the veins of your legs and lungs, including prevention of their recurrence

The recommended dose is 300 mg administered in the form of one 150 mg capsule twice a day.

If you are 80 years of age or older, the recommended dose is 220 mg administered in the form of one 110 mg capsule twice a day.

If you are using medicines that contain verapamil, you should be indicated a reduced dose of dabigatran of 220 mg taken in the form of one 110 mg capsule twice a day, because your risk of bleeding may increase.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe a dose of 220 mg administered in the form of one 110 mg capsule twice a day.

You can continue taking this medicine if it is necessary to restore your normal heartbeat through a procedure called cardioversion. Take this medicine exactly as your doctor has told you.

If you have had a medical device (vascular endoprosthesis) implanted in a blood vessel to keep it open in a procedure called percutaneous coronary intervention with vascular endoprosthesis, you may receive treatment with dabigatran once your doctor has decided that normal blood clotting control has been achieved. Take this medicine exactly as your doctor has told you.

Treatment of blood clots and prevention of their recurrence in children

Dabiprax should be taken twice a day, one dose in the morning and one dose in the evening, approximately at the same time every day. The administration interval should be as close as possible to 12 hours.

The recommended dose depends on weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose during treatment. Continue using all other medicines unless your doctor tells you to stop using one.

Table 1 shows the single and total daily doses of dabigatran in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Doses that require combinations of more than one capsule: 300 mg: two 150 mg capsules or four 75 mg capsules

260 mg: one 110 mg capsule plus one 150 mg capsule or one 110 mg capsule plus two 75 mg capsules

220 mg: two 110 mg capsules

185 mg: one 75 mg capsule plus one 110 mg capsule

150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabiprax

This medicine can be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew, or open the capsule to take only its contents, as this may increase the risk of bleeding.

Changing anticoagulant treatment

Do not change your anticoagulant treatment without specific instructions from your doctor.

If you take more Dabiprax than you should

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. There are specific treatment options available.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Dabiprax

Prevention of blood clot formation after knee or hip replacement surgery Take the remaining daily doses of dabigatran at the same time the next day.

Do not take a double dose to make up for forgotten doses.

Use in adults: Prevention of cerebral or systemic vascular obstruction by blood clot formation after irregular heartbeat and treatment of blood clots in the veins of your legs and lungs, including prevention of their recurrence

Use in children: Treatment of blood clots and prevention of their recurrence

A forgotten dose can be taken up to 6 hours before the next dose.

A forgotten dose should be omitted if the time remaining before the next dose is less than 6 hours. Do not take a double dose to make up for forgotten doses.

If you stop taking Dabiprax

Take this medicine exactly as prescribed. Do not stop your treatment with this medicine without consulting your doctor first, as the risk of developing a blood clot may be higher if you stop treatment too soon. Contact your doctor if you experience indigestion after taking dabigatran.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Dabigatran acts on blood coagulation; therefore, most adverse effects are related to signs such as bruising or bleeding. Episodes of major or severe bleeding may occur, which are the most serious adverse effects and, regardless of their location, can cause disability, be potentially life-threatening, or even cause death. In some cases, these bleedings may not be apparent.

If you experience any episode of bleeding that does not stop by itself or if you experience signs of excessive bleeding (exceptional weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under close observation or change your medication.

Inform your doctor immediately if you experience a severe allergic reaction that causes difficulty breathing or dizziness.

The possible adverse effects are detailed below, grouped according to their frequency of occurrence.

Prevention of blood clot formation after knee or hip replacement surgery

Frequent (may affect up to 1 in 10 people):

• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Anomalies in liver function tests

Uncommon (may affect up to 1 in 100 people):

• Bleeding may occur from the nose, stomach, or intestine, from the penis/vagina or urinary tract (including blood in the urine that stains the urine pink or red), from hemorrhoids, rectum, under the skin, from a joint, or after an injury or surgery
• Formation of hematomas or bruising after surgery
• Detection of blood in stool in a laboratory test
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent loose or liquid stools
• Feeling of nausea
• Pus discharge from a surgical wound
• Increased liver enzymes
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

Rare (may affect up to 1 in 1,000 people):

• Bleeding
• Bleeding may occur in the brain, at the site of a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bloody pus discharge from the site of a catheter in a vein
• Coughing up blood or sputum with blood spots
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Abdominal pain or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

Frequency not known (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

Prevention of cerebral or systemic vascular obstruction by blood clot formation developed after abnormal heart rhythm

Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach, or intestine, from the penis/vagina or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal pain or stomach pain
• Indigestion
• Frequent loose or liquid stools
• Feeling of nausea

Uncommon (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Anomalies in liver function tests

Rare (may affect up to 1 in 1,000 people):

• Bleeding may occur in a joint, at the site of a surgical incision, in a wound, at the site of an injection, or at the site of a catheter in a vein
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Decrease in the proportion of blood cells
• Increased liver enzymes
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

Frequency not known (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

In a clinical trial, the rate of heart attacks with dabigatran was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of recurrent blood clots in the veins of the legs and/or lungs

Frequent (may affect up to 1 in 10 people):

• Bleeding may occur from the nose, stomach, or intestine, from the rectum, penis/vagina, or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Indigestion

Uncommon (may affect up to 1 in 100 people):

• Bleeding
• Bleeding may occur in a joint or in a wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Formation of hematomas
• Coughing up blood or sputum with blood spots
• Allergic reaction
• Sudden change in skin color and physical appearance
• Itching
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling of nausea
• Vomiting
• Abdominal pain or stomach pain
• Frequent loose or liquid stools
• Anomalies in liver function tests
• Increased liver enzymes

Rare (may affect up to 1 in 1,000 people):

• Bleeding may occur at the site of a surgical incision, at the site of an injection, or at the site of a catheter in a vein or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Difficulty swallowing

Frequency not known (frequency cannot be estimated from available data):

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems
• Hair loss

In the clinical trial program, the rate of heart attacks with dabigatran was higher than with warfarin. The overall incidence was low. No imbalance was observed in the rate of heart attacks in patients treated with dabigatran compared to patients treated with placebo.

Treatment of blood clots and prevention of recurrent blood clots in children

Frequent (may affect up to 1 in 10 people):

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash with dark red, prominent, and itchy bumps, caused by an allergic reaction
• Sudden change in skin color and physical appearance
• Formation of hematomas
• Nasal bleeding
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling of nausea
• Frequent loose or liquid stools
• Indigestion
• Hair loss
• Increased liver enzymes

Uncommon (may affect up to 1 in 100 people):

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, or urinary tract (including blood in the urine that stains the urine pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or sputum with blood spots
• Abdominal pain or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood problems

Frequency not known (frequency cannot be estimated from available data):

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Severe allergic reaction that causes swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or in a wound, in a surgical incision, at the site of an injection, or at the site of a catheter in a vein
• Bleeding may occur from hemorrhoids
• Ulcer in the stomach or intestine (including ulcer in the esophagus)
• Anomalies in liver function tests

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dabiprax

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the box, blister, or bottle after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

• The active ingredient is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (in the form of mesilate).
• The other components are microcrystalline cellulose, sodium croscarmellose, crospovidone, tartaric acid pellets, hydroxypropylcellulose, mannitol (E-421), talc, and magnesium stearate.
• The capsule shell contains red iron oxide (E-172), titanium dioxide (E-171), and hypromellose.
• The black printing ink contains shellac, propylene glycol, black iron oxide (E-172), concentrated ammonia solution, and potassium hydroxide.

Appearance of the Product and Package Contents

Dabiprax 110 mg are hard capsules (approx. 22 mm in length) with a pink, opaque cap and body, printed with "DA110".

Dabigatran etexilate is available in packages containing 10, 30, and 60 hard capsules in aluminum/aluminum blisters with a desiccant.

Marketing Authorization Holder

PTR Pharma Consulting, Lda.

Rua Brito Pais, 8C,

1495-028 Algés,

Portugal

Manufacturer

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park Paola

PLA 3000

Malta

Date of the Last Revision of this Prospectus: June 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/